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BioWorld - Friday, May 16, 2025
Home » Topics » Regulatory » Phase II

Phase II
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Blood pressure cuff

Kardia-2 prods Alnylam’s zilebesiran forward, hypertension back

March 5, 2024
By Karen Carey
The RNAi therapeutic zilebesiran, which was the focus of a 2023 $2.8 billion deal between Alnylam Pharmaceuticals Inc. and Roche Holding AG, demonstrated significant systolic blood pressure reductions in patients with mild to moderate hypertension who were part of the Kardia-2 phase II study.
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Immune

Stemcyte cleared to study umbilical cord blood stem cell therapy for post-COVID syndrome

Aug. 30, 2022
Stemcyte Inc. has received IND approval from the FDA for a phase II trial using umbilical cord blood stem cell therapy for post-COVID syndrome, or long COVID.
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Shock away? Adrenomed’s adrecizumab hits phase II endpoint in septic shock

Feb. 26, 2020
By Cormac Sheridan
DUBLIN – Adrenomed AG disclosed Feb. 21 that its first-in-class antibody, adrecizumab, hit the primary safety and tolerability endpoint of a phase II trial in septic shock.
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Neurotrope shares crushed on phase II bryostatin-1 fizzle in Alzheimer's

Sep. 10, 2019
By Michael Fitzhugh
Shares of New York-based Neurotrope Inc. (NASDAQ:NTRP) fell 77.3% to close at a record low of $1 Monday after a phase II study of its lead candidate, bryostatin-1, failed to outperform a placebo in helping people with moderate to severe Alzheimer's disease (AD) achieve improvement on a standardized measure of cognition.
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Aridis study failure ends development of AR-105

Sep. 4, 2019
By Lee Landenberger
Following its phase II stumble of AR-105, Aridis Pharmaceuticals Inc. is dropping its development of the IgG1 monoclonal antibody. The study failed to meet its primary endpoint of showing superiority in clinical cure rates compared to placebo for treating ventilator-associated pneumonia caused by gram-negative Pseudomonas aeruginosa.
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Going all the way, NMDA work sped up as chances weighed for big players

July 12, 2019
By Randy Osborne
Word from the FDA to Axsome Therapeutics Inc. about the effort with oral N-methyl-D-aspartate (NMDA) receptor antagonist AXS-05 in depression – and the company's accelerated push with the compound – had Wall Street watching the NMDA space with even more interest than usual.
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Bionomics' BNC-210 fails in agitation, hope hangs on PTSD

July 8, 2019
By Tamra Sami
PERTH, Australia – Adelaide, Australia-based Bionomics Inc. reported another trial failure with its lead compound, BNC-210, in elderly patients with agitation, but it is still clinging on to hopes that the compound will show a clinical benefit for post-traumatic stress disorder (PTSD).
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Patient Experience Still Undervalued in Regulating Drugs

Oct. 28, 2013
By Marie Powers
As I write this, I’m sitting in the University of British Columbia/Vancouver General Hospital (UBC/VGH) Eye Care Centre, where my husband, Chuck, is completing post-tests at the conclusion of a six-month study on prosopagnosia, otherwise known as face blindness. The condition isn’t treatable with drugs – not yet, at least – but it’s nonetheless disabling, prompting researchers at several centers in North America and Europe to work collaboratively and seek to help patients carry on with their lives. Clinical studies of prosopagnosia have, so far, informed researchers more about the causes and structural manifestations of the disease than about potential...
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World’s Oldest Clinical Trial . . . and Health Economics Not Far Behind

Nov. 4, 2011
By Trista Morrison
How old is our clinical trial system? The first randomized clinical trial was conducted in 1946. British epidemiologist Sir Austin Bradford Hill used randomization to test a pertussis vaccine and a tuberculosis treatment. But according to an article in the British Medical Journal, the concept of randomization was used even earlier, in agriculture experiments in the 1920s. And even before randomization, controlled clinical trials were taking place as early as 1747, when James Lind conducted an experiment in which groups of sailors with scurvy were given various supplements, including citrus fruits. Yet at the recent Foley & Lardner Life Sciences...
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Race To Nowhere

May 19, 2011
By Anette Breindl
Racial profiling – long in the realm of bad law enforcement – was criticized as bad medicine, too, in a recent paper by scientists from the Mount Sinai School of Medicine. The reason? As the authors put it, “cosmopolitan cities now include many individuals whose genetic heritage is drawn from multiple continental origins.” In other words, there’s no such thing as racial purity. In their paper, which was published in PLoS ONE and which you can find here (http://ow.ly/4YxK6) the team genotyped nearly 1,000 participants of Biobank, a program that collects DNA and plasma samples to aid in genomic and...
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